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A Study to Investigate the Safety and Efficacy of Undiluted Intravenous Infusion of I.V.-Hepabig Inj.
Sponsor: GC Biopharma Corp
Summary
The purpose of this study is to evaluate the efficacy and safety of undiluted intravenous infusion of I.V.-Hepabig inj. in post-liver transplant patients
Official title: A Phase 3b Study to Investigate the Safety and Efficacy of Undiluted Intravenous Infusion of I.V.-Hepabig Inj. in Post-liver Transplant Patients
Key Details
Gender
All
Age Range
18 Years - 64 Years
Study Type
INTERVENTIONAL
Enrollment
105
Start Date
2023-04-13
Completion Date
2026-06-30
Last Updated
2025-06-25
Healthy Volunteers
No
Conditions
Interventions
Undiluted I.V.-Hepabig inj(GC5103)
undiluted I.V.-Hepabig inj(GC5103) 10,000 International Unit
Diluted I.V.-Hepabig inj(GC5103)
Diluted I.V.-Hepabig inj(GC5103) 10,000 International Unit
Locations (8)
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea
Ajou University Medical Center
Suwon, Gyeonggi-do, South Korea
Asan Medical Center
Seoul, Seoul, South Korea
Inje University Haeundae Paik Hospital
Busan, South Korea
Chungnam National University Hospital
Daejeon, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea